Assay analysis

Abstract

Apparatus and assemblies for the detection of at least one analyte in a sample are shown and described. In one embodiment, the assembly generates a test result from an assay and includes an integrated reader and incubator, wherein the incubator incubates the assay as the reader generates the test result. The reader typically has an optical detector aligned with a light source for detecting a plurality of transmission of light on the assay. The result is systems and methods to improve the detection of the presence and/or absence of at least one analyte in a sample.

What is claimed is: 
     
       1. An apparatus to generate a test result from an assay, said apparatus comprising:
 a. an incubator adapted to incubate said assay in at least one incubation environment; and 
 b. a reader having an optical detector aligned with a light source for detecting a first transmission of light on said assay and detecting at least a subsequent transmission of light on said assay that undergoes a change, when present, when contacted with a sample to generate said test result, and
 wherein said apparatus synchronizes incubating said assay with detecting said transmissions of light on said assay to generate said test result. 
 
 
     
     
       2. The apparatus of  claim 1 , wherein said apparatus is adapted to perform a continuous image detection of said assay. 
     
     
       3. The apparatus of  claim 1 , further including an optics housing enclosing said optical detector and adapted to block debris from contact with said optical detector. 
     
     
       4. The apparatus of  claim 1 , further including a multichannel reader, whereby an assay reference coding activates a corresponding channel in said multichannel reader. 
     
     
       5. The apparatus of  claim 1 , wherein said reader monitors at least one pre-test parameter after said optical detector has acquired at least one image detection on said assay. 
     
     
       6. The apparatus of  claim 5 , wherein the image detection is an optical reflectance value. 
     
     
       7. The apparatus of  claim 1 , wherein said assay includes at least one test line and at least one control line, and whereby a theoretical reflectance value is a comparison between a reflectance value at said test line and a reflectance value at said control line. 
     
     
       8. The apparatus of  claim 7 , wherein an inadequate flow of sample along said assay triggers a detectable signal to deactivate said apparatus. 
     
     
       9. The apparatus of  claim 7 , wherein a reflectance value on said assay that is inconsistent with a theoretical reflectance value indicates a prior analyte test result development on said assay. 
     
     
       10. The apparatus of  claim 1 , wherein said incubator includes an insulated base. 
     
     
       11. The apparatus of  claim 1 , wherein said incubator is a temperature adjustable incubator comprising at least one temperature control. 
     
     
       12. The apparatus of  claim 11 , wherein said incubator compensates for localized temperature variations with an analog, proportional control circuit. 
     
     
       13. The apparatus of  claim 1 , wherein said light source comprises discrete light sources having light emitting diodes. 
     
     
       14. The apparatus of  claim 13 , wherein said light source includes a first mirror below said light source. 
     
     
       15. The apparatus of  claim 14 , wherein said light source includes a focusing lens adapted to receive light from said first mirror. 
     
     
       16. The apparatus of  claim 1 , further including a housing adapted to substantially enclose said reader and said incubator. 
     
     
       17. The apparatus of  claim 1 , further including a user interface having a display board. 
     
     
       18. An assembly to generate a test result from an assay, said assembly comprising:
 a. a reader having an optical detector detecting a first transmission of light on said assay and detecting at least a subsequent transmission of light on said assay; 
 b. an incubator incubating said assay; and 
 c. a housing substantially enclosing said incubator and said reader, said housing includes a cavity adapted to secure said assay and insulation adapted to withstand deformation during said incubation, and 
 wherein said incubator incubates said assay concurrently as said reader generates said test result. 
 
     
     
       19. The assembly of  claim 18 , further including a user interface having an integrated circuit board supporting a display board. 
     
     
       20. The assembly of  claim 18 , wherein said assembly performs continuous image detection of said assay to generate said test result.